Cluster randomized trials #
- Copas, A. J., Lewis, J. J., Thompson, J. A., Davey, C., Baio, G., & Hargreaves, J. R. Designing a stepped wedge trial: three main designs, carry-over effects and randomisation approaches. Trials. 2015;16(1), 1-12.
- Amanyire G, Semitala FC, Namusobya J, Katuramu R, Kampiire L, Wallenta J, Charlebois E, Camlin C, Kahn J, Chang W, Glidden D. Effects of a multicomponent intervention to streamline initiation of antiretroviral therapy in Africa: a stepped-wedge cluster-randomised trial. The lancet HIV. 2016 Nov 1;3(11):e539-48.
- Hemming K, Taljaard M, McKenzie JE, Hooper R, Copas A, Thompson JA, Dixon-Woods M, Aldcroft A, Doussau A, Grayling M, Kristunas C. Reporting of stepped wedge cluster randomised trials: extension of the CONSORT 2010 statement with explanation and elaboration. bmj. 2018 Nov 9;363.
External validity #
- Westreich D, Edwards JK, Lesko CR, Cole SR, Stuart EA. Target Validity and the Hierarchy of Study Designs. Am J Epidemiol. 2019 Feb 1;188(2):438-443. PMID: 30299451; PMCID: PMC6357801.
- Loudon K, Treweek S, Sullivan F, Donnan P, Thorpe KE, Zwarenstein M. The PRECIS-2 tool: designing trials that are fit for purpose. bmj. 2015 May 8;350.
- Mehrotra, M.L., Petersen, M.L., & Geng, E.H. Understanding HIV Program Effects: A Structural Approach to Context Using the Transportability Framework. Journal of Acquired Immune Deficiency Syndrome. 2019; 82. p.199-205.
Adaptive interventions #
- Kilbourne A, Chinman M, Rogal S, Almirall D. Adaptive designs in implementation science and practice: their promise and the need for greater understanding and improved communication. Annual Review of Public Health. 2024;45.
- Smith SN, Almirall D, Choi SY, Koschmann E, Rusch A, Bilek E, Lane A, Abelson JL, Eisenberg D, Himle JA, Fitzgerald KD. Primary aim results of a clustered SMART for developing a school-level, adaptive implementation strategy to support CBT delivery at high schools in Michigan. Implementation Science. 2022 Dec;17(1):1-9.
- Geng EH, Mody A, Powell BJ. On-the-go adaptation of implementation approaches and strategies in health: emerging perspectives and research opportunities. Annual Review of Public Health. 2023 Apr 3;44(1):21-36.
- Miller CJ, Barnett ML, Baumann AA, Gutner CA, Wiltsey-Stirman S. The FRAME-IS: a framework for documenting modifications to implementation strategies in healthcare. Implementation Science. 2021 Apr 7;16(1):36.
- Wingood GM, DiClemente RJ. The ADAPT-ITT model: a novel method of adapting evidence-based HIV Interventions. JAIDS Journal of Acquired Immune Deficiency Syndromes. 2008 Mar 1;47:S40-6.
- Lei H, Nahum-Shani I, Lynch K, Oslin D, Murphy SA. A “SMART” design for building individualized treatment sequences. Annu Rev Clin Psychol. 2012;8:21-48. PMID: 22224838; PMCID: PMC3887122.
- Quanbeck A, Almirall D, Jacobson N, Brown RT, Landeck JK, Madden L, Cohen A, Deyo BMF, Robinson J, Johnson RA, Schumacher N. The Balanced Opioid Initiative: protocol for a clustered, sequential, multiple-assignment randomized trial to construct an adaptive implementation strategy to improve guideline-concordant opioid prescribing in primary care. Implement Sci. 2020 Apr 25;15(1):26. doi: 10.1186/s13012-020-00990-4.
Hybrid designs #
- Curran GM, Landes SJ, McBain SA, Pyne JM, Smith JD, Fernandez ME, Chambers DA, Mittman BS. Reflections on 10 years of effectiveness-implementation hybrid studies. Frontiers in Health Services. 2022 Dec 8;2:1053496.
- Fortney JC, Curran GM, Lyon AR, Check DK, Flum DR. Similarities and Differences Between Pragmatic Trials and Hybrid Effectiveness-Implementation Trials. Journal of General Internal Medicine. 2024 Apr 16:1-9.
- Knox, J., Schwartz, S., Duncan, D. T., Curran, G., Schneider, J., Stephenson, R., … & Geng, E. (2023). Proposing the observational–implementation hybrid approach: designing observational research for rapid translation. Annals of epidemiology, 85, 45-50.
- Edelman EJ, Dziura J, Deng Y, Bold KW, Murphy SM, Porter E, Sigel KM, Yager JE, Ledgerwood DM, Bernstein SL. A SMARTTT approach to treating tobacco use disorder in persons with HIV (SMARTTT): rationale and design for a hybrid type 1 effectiveness-implementation study. Contemporary clinical trials. 2021 Nov 1;110:106379.
- Edelman EJ, Dziura J, Esserman D, Porter E, Becker WC, Chan PA, Cornman DH, Rebick G, Yager J, Morford K, Muvvala SB. Working with HIV clinics to adopt addiction treatment using implementation facilitation (WHAT-IF?): rationale and design for a hybrid type 3 effectiveness-implementation study. Contemporary Clinical Trials. 2020 Nov 1;98:106156.
- Garner BR, Gotham HJ, Chaple M, Martino S, Ford JH, Roosa MR, Speck KJ, Vandersloot D, Bradshaw M, Ball EL, Toro AK. The implementation and sustainment facilitation strategy improved implementation effectiveness and intervention effectiveness: Results from a cluster-randomized, type 2 hybrid trial. Implementation Research and Practice. 2020 Sep;1:2633489520948073.
Qualitative and ethnographic #
- Ware, N.C. Qualitative contributions to implementation research on HIV prevention and treatment. JAIDS Journal of Acquired Immune Deficiency Syndromes.2019; 1(82), 217-221. https://doi.org/10.1097/qai.0000000000002214
- Hamilton AB, Finley EP. Qualitative methods in implementation research: An introduction. Psychiatry Res. 2019 Oct;280:112516. doi: 10.1016/j.psychres.2019.112516. Epub 2019 Aug 10. PMID: 31437661; PMCID: PMC7023962. A general overview paper
- Ominyi J, Eze U, Agom D, Alabi A, Nwedu A. Implementing Evidence-Based Practice in Critical Care Nursing: An Ethnographic Case Study of Knowledge Use. J Adv Nurs. 2025 Jul 4. doi: 10.1111/jan.70054. Epub ahead of print. PMID: 40613643. An example of how ethnographic data can be used to generate insights on implementation context and determinants of EBP implementation
- Greenhalgh T, Wherton J, Papoutsi C, Lynch J, Hughes G, A’Court C, Hinder S, Fahy N, Procter R, Shaw S. Beyond Adoption: A New Framework for Theorizing and Evaluating Nonadoption, Abandonment, and Challenges to the Scale-Up, Spread, and Sustainability of Health and Care Technologies. J Med Internet Res. 2017 Nov 1;19(11):e367. doi: 10.2196/jmir.8775. PMID: 29092808; PMCID: PMC5688245. An example of how ethnographic and qualitative data can be used to generate a theoretical framework
- Broderick, K., Vaidyanathan, A., Ponticiello, M. et al. Generalizing from qualitative data: a case example using critical realist thematic analysis and mechanism mapping to evaluate a community health worker-led screening program in India. Implementation Sci 19, 81 (2024). https://doi.org/10.1186/s13012-024-01407-2 Our paper showing an example of using qualitative data to identify mechanisms driving both clinical and implementation outcomes
Pragmatic Trials #
- Bhasin S, Gill TM, Reuben DB, Latham NK, Ganz DA, Greene EJ, Dziura J, Basaria S, Gurwitz JH, Dykes PC, McMahon S. A randomized trial of a multifactorial strategy to prevent serious fall injuries. New England journal of medicine. 2020 Jul 9;383(2):129-40.
Realist #
- Rycroft-Malone J, McCormack B, Hutchinson AM, DeCorby K, Bucknall TK, Kent B, Schultz A, Snelgrove-Clarke E, Stetler CB, Titler M, Wallin L, Wilson V. Realist synthesis: illustrating the method for implementation research. Implement Sci. 2012 Apr 19;7:33. PMID: 22515663; PMCID: PMC3514310.
- Singh NS, Kovacs RJ, Cassidy R, Kristensen SR, Borghi J, Brown GW. A realist review to assess for whom, under what conditions and how pay for performance programmes work in low- and middle-income countries. Soc Sci Med. 2021 Feb;270:113624. PMID: 33373774.
- Greenhalgh T, Kristjansson E, Robinson V. Realist review to understand the efficacy of school feeding programmes. BMJ. 2007 Oct 27;335(7625):858-61 PMID: 17954518; PMCID: PMC2043412.
- Bonell C, Fletcher A, Morton M, Lorenc T, Moore L. Realist randomised controlled trials: a new approach to evaluating complex public health interventions. Social science & medicine. 2012 Dec 1;75(12):2299-306.